title: A phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G05-92.
abstract: BACKGROUND
  On the basis of the promising activity of cetuximab and radiation therapy for head and neck cancers, we evaluated the efficacy of this regimen followed by surgery in patients with resectable esophageal cancer. This was a phase II, open-label, single-arm, multicenter study of patients with potentially resectable esophageal cancer.
  
  
  METHODS
  Patients received two weekly doses of cetuximab followed by weekly cetuximab combined with radiation therapy for 6 weeks. After a 6- to 8-week rest, patients' primary tumor was resected. The main objective was to evaluate pathologic complete response (pCR) rate in the primary tumor after cetuximab and radiation therapy.
  
  
  RESULTS
  Thirty-nine patients completed the study. Most patients were men (93%), median age was 64 years, performance status was 0 to 1 (95%), patients had a histology of adenocarcinoma (78%), and tumors were located in the esophagus (63%). Grade 3 toxicities in more than 5% of patients included dysphagia (17%), anorexia and dehydration (7%), and dyspnea, fatigue, hypernatremia (5%). Grade 5 aspiration occurred in 2% (1 patient). Four patients died, two from disease progression, one from aspiration pneumonia postsurgery, and one from septic shock. Thirty-one patients (76%) underwent esophagectomy. The pCR rate was 36.6% by intention-to-treat and 48% for patients who underwent esophagectomy. The pCR by histology was 6 of 9 (67%) for squamous cell carcinomas and 9 of 32 (28%) for adenocarcinoma. Earlier-stage disease was associated with increased pCR (IIA 70%, IIB 29%, III 28%).
  
  
  CONCLUSIONS
  Cetuximab and radiation therapy results in a pCR rate that seems at least comparable with that of chemotherapy and radiation therapy. This regimen may be better tolerated than preoperative chemotherapy and radiation therapy in patients with resectable esophageal cancers.
authors.affiliation: *US Oncology Research, McKesson Specialty Health, The Woodlands, Texas, and Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas; †Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana; ‡Community Oncology Center, Kokomo, Indiana; §University of Texas Southwestern Medical Center at Dallas, Dallas, Texas; and ‖Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Carlos R
authors.initials: CR
authors.lastname: Becerra
authors.forename: Nasser
authors.initials: N
authors.lastname: Hanna
authors.forename: Andrew David
authors.initials: AD
authors.lastname: McCollum
authors.forename: Naftali
authors.initials: N
authors.lastname: Becharm
authors.forename: Robert D
authors.initials: RD
authors.lastname: Timmerman
authors.forename: Michael
authors.initials: M
authors.lastname: DiMaio
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Kesler
authors.forename: Menggang
authors.initials: M
authors.lastname: Yu
authors.forename: Tong
authors.initials: T
authors.lastname: Yan
authors.forename: Hak
authors.initials: H
authors.lastname: Choy
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D000068818:Cetuximab; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000473:pathology / Q000628:therapy*; D016629:Esophagectomy; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011879:Radiotherapy Dosage; D012074:Remission Induction
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab